Careers at Hansen Medical
Senior R&D Catheter Engineer / R&D Manager
SUMMARY:
The successful applicant will work in a technical leadership role and lead product development teams through all phases of new catheter product development including ideation, clinical applications, concept development, detailed engineering and testing, DFM and transfer to operations. The job involves significant individual contribution at the technical level but more importantly, the candidate must have the ability to lead a team of 10-15 engineers including catheter design engineers, controls engineers, process development engineers, manufacturing engineers and test engineers. This candidate will be responsible for ensuring the output from this team results in an integrated product that meets performance, schedule and cost requirements. This technical team leader will be expected to challenge all technical aspects of the project and insist on deeper technical rigor and increased optimization/understanding where appropriate but also know when to freeze the design and execute on design control deliverables. Therefore, the candidate must have a proven track record of innovation, making sound technical decisions and getting integrated products to market with aggressive timelines.
If you have been through the full product development process several times, if you have management experience but you have an affinity for technical details and are still interested in hands on work, if you feel you know the best practices and watch-outs when developing complex disposable medical devices, if you are an advocate of design for six sigma and robust design techniques and you are interested in coaching and leading other talented engineers, this position is for you.
RESPONSIBILITIES:
- Design and develop catheter prototypes and work with cross functional teams to identify, plan and execute tasks to bring products from concept through to market release.
- Provide technical leadership to development teams.
- Interface with marketing and clinical to ensure customer requirements are understood and transferred correctly to engineering specifications.
- Provide technical guidance to teams to develop and improve manufacturing processes to pilot production level
- Lead team through verification and validation of new product designs
- Prepare project plans, cost targets and schedules for new product development
- Choose new technologies and materials and identify and interact with strategic vendors to obtain engineering materials, processes, and equipment
- Provide guidance to teams to perform statistical analysis of test results in relation to design specifications and test objectives to understand design capabilities to tolerances.
- Assist in debugging and optimizing system performance, on bench and in vivo studies
- Assist in the preparation and review of patent applications
REQUIREMENTS
- 8 years, minimum, experience as a development engineer in the medical device industry
- Minimum of 2 years in technical lead role integrating the work of multiple project engineers.
- Bachelor’s degree in Mechanical Engineering, Master’s degree preferred.
- Extensive knowledge and proven track record of catheter design, (preferably with steerable catheters) manufacturing process skills and rapid product development.
- Must have a demonstrated ability to effectively and clearly communicate technical concepts, ideas and knowledge to other individuals and teams.
- Strong analytical and problem solving skills, as well as a good background in the product development process.
- Experience working with ISO requirements, GMP guidelines, FDA regulations, medical device design control, and manufacturing scale-up processes.
- Previous small-company experience a plus.
- Strong creative and innovative ability.
- Trained in Design for Six Sigma practices, statistical data analysis, DOEs, Gage R&Rs, a plus
- Experienced at presenting technical data to senior management to help with decision making
Bold Text identifies critical responsibilities/requirements.
Please submit your information to: recruiting@hansenmedical.com